Class 2 Device Recall IMRIS HFD100 head fixation device

• Date Initiated by Firm: February 17, 2022
• Create Date: April 14, 2022
• Recall Status: Terminated on May 15, 2024
• Recall Number: Z-0934-2022
• Recall Event ID: 89713
• 510(K)Number: K103493
• Product Classification: Holder, head, neurosurgical (skull clamp) - Product Code HBL
• Product: Trumpf Mount Clamp Assembly (table adapter component), part #118704-000, a component of the IMRIS HFD100 head fixation device, models #119629-000 and #119630-000, which are used with ORT400 operating room tables.
• Code Information: Model #119629-000, UDI 00857534006592; and model #119630-000, UDI 00857534006615. Serial numbers: 10008164, 10007550, 10007555, 10008864, 10008160, 10008161, 10008859, 10008860, 10010668, 10010669, 10010673, 10010674, 10010672, 10007556, 10007557, 10008862, 10008861, 10008158, 10008159, 10008863, 10008165, 10007558, 10008865, and 10010675.
• Recalling Firm/ Manufacturer: Deerfield Imaging, Inc.; 5101 Shady Oak Rd S; Minnetonka MN 55343-4100
• For Additional Information Contact: Customer Support; 866-475-0525
• Manufacturer Reason for Recall: Reports have been received that after normal or routine lateral forces are applied to the head fixation device, the split block clamp may deflect (rotationally around the axis) and not return to within acceptable distance from its prior position after the force is removed. In order to reduce deflection at the table mount location, users have tightened the hand knob screw to a degree that it is then difficult to untighten it later in the clinical workflow. Rotational movement at the table attachment point could result in HFD movement going unnoticed, which could result in a situation where surgical or medical intervention is necessary, a situation where navigation needs to be reestablished, or a situation resulting in extended time under anesthesia for the patient. It may also be difficult to loosen the mount clamp component after use, potentially leading to ergonomic injury or a workaround during equipment teardown.
• FDA Determined Cause: Device Design
• Action: The recalling firm issued letters dated 2/17/2022 to its consignees via FedEx and email. The consignee was informed of the issue and that the firm is taking corrective actions to minimize the potential risk of injury, and informed they have been identified as having one or more of the affected mount clamp components that requires replacement. Until the HFD100 mount clamp component is replaced, the firm recommends preventive actions be taken that include: (1) Ensure the instructions in the Operator Manual for proper HFD100 linkage assembly are followed to produce rigid fixation; and (2) Ensure there is no movement of the mount clamp component and of the HFD100 linkages prior to clinical use. The consignee is requested to confirm the details provided on the last page of the letter and return the response to the recalling firm. The details to be confirmed are whether the facility still has the HFD mount clamp component at their facility and requests the serial number and whether it is currently in use.
• Quantity in Commerce: 24
• Distribution: Worldwide distribution - US Nationwide distribution in the states of AL, FL, GA, MA, MN, NC, NY, OH, and TX. The countries of Sweden and Switzerland.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = HBL and Original Applicant = IMRIS, INC.